Zithromax May Cause Life Threatening Liver and Kidney Damage

7/23/2015 First, it was Stevens Johnson Syndrome (SJS), potentially fatal rash, now Zithromax may cause life threatening liver and kidney damage. Zithromax (azithromycin), often called Z-pak or Zmax, is a widely used antibiotic for the treatment of bacterial infections such as pneumonia, ear infections, skin infections and tonsillitis. It’s popular due to the relatively short


FDA Sends C.R. Bard a Stern Warning for Unapproved Devices

7/23/2015 Los Angeles Food and Drug Administration (FDA) compliance officer Dr. Raymond W. Brullo issued a scathing warning letter to Thomas Ring, the CEO of New Jersey-based device manufacturer C.R. Bard. The letter contained a litany of violations regarding several single-use devices for IVC and foreign body retrieval. The letter follows a series of inspections


First Indictment in VA Wait-Time Scandal Unveiled in Georgia

7/21/2015 A facility manager for Augusta, Georgia’s Charlie Norwood VA Medical Center has been indicted on 50 counts of instructing his staff to falsify medical records for patients seeking treatment outside of the VA health system. Cathedral Henderson pleaded not-guilty to the charges in U.S District Court in Savannah on Friday. Henderson managed revenue and


Medtronic’s Shiley Trach Tube Receives FDA’s Most Critical Recall

7/18/2015 The Food and Drug Administration (FDA) has given the recall of Medtronic’s Shiley neonatal and pediatric tracheostomy tubes a Class I label, its most serious designation. Under a Class I label, the FDA believes that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Last


NICU Identity Mistakes Cause “Wrong Patient Errors”

7/17/2015 Art imitates life. A baby is born and must be whisked away to the neonatal intensive care unit (NICU) due to serious complications or prematurity. These are time-sensitive situations and don’t allow for much parent/child contact including naming the baby, unless the parents already have a name chosen. Standard procedure is to give the


Celgene to Acquire Receptos for $7.2 Billion in Continuation of Buying Spree

7/15/2015 Biotech manufacturer Celgene is making an earnest push to become one of the industry’s leaders following a wave of transactions aimed at increasing long-term sustainability. Celgene’s current success is largely based on the popularity of its breakthrough cancer drug, Revlimid; however Celgene is attempting to set itself up for future growth when Revlimid’s patent



FDA to Review Birth Control Device Essure due to Side Effect Concern

The U.S. Food and Drug Administration (FDA) is joining famous environmental and consumer activist Erin Brockovich in its skepticism of Bayer’s popular birth control device, Essure. Bayer claims that the coil-like device is the only non-surgical permanent form of birth control on the market. The FDA announced last month that it will be conducting a


More Harm Than Good – Dilantin SJS

7/10/2015 Another drug has hit the lawsuit trail for horrific side effects and manufacturer failure to warn. I just published a piece on Zithromax and SJS and now, Dilantin (generic Phenytoin) is on the hook for the same issue – causing Stevens Johnson Syndrome. It’s yet one more case of a drug potentially doing more


CDC Found Causal Link Between SSRIs and Birth Defects

7/9/2015 It was only a matter of time before the Centers for Disease Control (CDC) spoke out on the issue of taking SSRI antidepressants while pregnant and birth defects. The CDC found causal link between SSRIs and birth defects. The study, led by Jennita Reefhuis, an epidemiologist in the birth defects branch of the CDC,